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A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524364
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Pulsed Field Ablation (PFA) Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)
Actual Study Start Date : August 23, 2020
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Participants with Paroxysmal Atrial Fibrillation (PAF)
Participants with PAF and who are candidates for catheter ablation will be enrolled.
Device: Pulsed Field Ablation (PFA) Therapy
Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).




Primary Outcome Measures :
  1. Number of Participants with of Primary Adverse Events (PAEs) [ Time Frame: Within one week (7 days) post-procedure ]
    Participants with incidence of Primary Adverse Events (PAEs) (within seven (7) days of the initial mapping and ablation procedure) will be reported. PAEs include the adverse events like Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction and pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/CVA, thromboembolism, transient Ischemic Attack (TIA)

  2. Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure [ Time Frame: 91-365 Days ]
    Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.


Secondary Outcome Measures :
  1. Number of Participants who Achieved Acute Procedural Success [ Time Frame: 91-365 Days ]
    Acute procedural success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge.

  2. Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure [ Time Frame: 91-365 Days ]
    Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.

  3. Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [ Time Frame: Baseline, Month 3, 6 and 12 ]
    An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
  • Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
  • Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
  • Willing and capable of providing consent
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Previous left atrium (LA) ablation or surgery
  • Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
  • Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
  • Severe dilatation of the LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524364


Contacts
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Contact: Macours Nathalie +32 ext 479 97 05 05 nmacours1@its.jnj.com

Locations
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Belgium
OLV Aalst Recruiting
Aalst, Belgium, 9300
Canada
Southlake Regional Health Centre Not yet recruiting
Newmarket, Canada, ON L3Y 2P9
Croatia
University Hospital Center Split Not yet recruiting
Split, Croatia, 21000
Czechia
Nemocnice na Homolce Recruiting
Prague, Czechia, 150 30 District 5
Italy
Ospedale Generale Regionale "F. Miulli" Not yet recruiting
Acquaviva Delle Fonti (Bari), Italy, 70021
Lithuania
Vilnius University Hospital Recruiting
Vilnius, Lithuania, 8661
Sponsors and Collaborators
Biosense Webster, Inc.
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT04524364    
Other Study ID Numbers: BWI_2019_08
BWI_2019_08 ( Other Identifier: Biosense Webster, Inc. )
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes